510(k) · Cleared
ClearedLympha Press 201MAX, Model 201MAX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mego Afek AC, Ltd. · JOW Sleeve, Limb, Compressible
Cleared on May 20, 2010 as substantially equivalent to K082149 (Mego Afek AC, Ltd., 2008) and 1 other predicate after a 71-day review. Its family tree reaches back 3 generations to 1981. 14 later devices descend from it.
- Decided
- May 20, 2010
- Review
- 71 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K810338 (1981). 4 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK810338 Lympha PressMego Afek · 1981
- 2 generations backK013331 Lympha Press Plus DeviceMego Afek · 2001
- 1 generation backK082149 Lympha Press Optimal, Model# 1201APMego Afek AC, Ltd. · 2008
- This deviceK100677 Lympha Press 201MAX, Model 201MAXMego Afek AC, Ltd. · 2010
- Descendant · cites it directly · 12 of its ownK123647 Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK131420 Petite Basic System 701 EltMego Afek AC, Ltd. · 2013
- Descendant · 2 generations on · 4 of its ownK143185 entré Model PD08-UTactile Systems Technology, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK172770 AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK193069 AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K123647Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013 · cites it directly12descendants
- K131420Petite Basic System 701 EltMego Afek AC, Ltd. · 2013 · cites it directly5descendants
- K143185entré Model PD08-UTactile Systems Technology, Inc. · 2015 · 2 generations on4descendants
- K172770AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2018 · 2 generations on3descendants
- K193069AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2019 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810338 | Lympha Press | Mego Afek | 1981 | — |
| −2 | K013331 | Lympha Press Plus Device | Mego Afek | 2001 | — |
| −1 | K082149 | Lympha Press Optimal, Model# 1201AP | Mego Afek AC, Ltd. | 2008 | — |
| 0 (this device) | K100677 | Lympha Press 201MAX, Model 201MAX | Mego Afek AC, Ltd. | 2010 | — |
| +1 | K123647 | Circuflow 5208 Sequential Compression Device | Devon Medical, Inc. | 2013 | — |
| +1 | K131420 | Petite Basic System 701 Elt | Mego Afek AC, Ltd. | 2013 | — |
| +2 | K143185 | entré Model PD08-U | Tactile Systems Technology, Inc. | 2015 | — |
| +2 | K172770 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | 2018 | — |
| +3 | K193069 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOW device
- #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082149 | Lympha Press Optimal, Model# 1201APSummary page 1…mpha Press 2O1MAXTMA Compression Therapy Device is substantially equivalent to a combination of the following predicate devices: - Lympha Press Optimal Model 1201lAP (K082 149) manufactured also by Mego Afek, Ltd (Israel). Lympha Press Optimal Model 12O1AP is a compressible limb sleeve, similar… | 2008 |
| * | K013331 | Lympha Press Plus DeviceSummary page 1…Press Optimal Model 12O1AP is a compressible limb sleeve, similar to the Model Lympha Press 201 MAXTM Compression Therapy Device. - Lympha Press Plus Model 1033 (K013331) manufactured also by Mego Afek, Ltd (Israel). Lympha Press Plus Model 1033 is a compressible limb sleeve, similar to the… | 2001 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K123647 (Devon Medical, Inc., 2013) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K082149.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JOW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOW
168in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOW
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOW
24in 2025
MAUDE reports naming product code JOW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 66 | 0 | 12 |
| 2008 | 4 | 112 | 7 | 36 |
| 2009 | 3 | 84 | 0 | 45 |
| 2010 | 18 | 71 | 2 | 66 |
| 2011 | 11 | 104 | 3 | 50 |
| 2012 | 13 | 63 | 2 | 100 |
| 2013 | 17 | 94 | 0 | 169 |
| 2014 | 16 | 91 | 0 | 93 |
| 2015 | 10 | 160 | 0 | 137 |
| 2016 | 9 | 121 | 0 | 150 |
| 2017 | 9 | 116 | 1 | 149 |
| 2018 | 11 | 136 | 0 | 114 |
| 2019 | 11 | 88 | 1 | 102 |
| 2020 | 14 | 158 | 0 | 50 |
| 2021 | 16 | 132 | 0 | 34 |
| 2022 | 7 | 80 | 0 | 27 |
| 2023 | 6 | 160 | 0 | 57 |
| 2024 | 8 | 197 | 0 | 30 |
| 2025 | 7 | 168 | 0 | 24 |
| 2026 | 6 | 252 | 0 | — |
What is it indicated for?
Primary lymphedema
Secondary lymphedema
Venous insufficiency
Venous stasis ulcers
Dysfunction of the muscle pump
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100677: Lympha Press 201MAX, Model 201MAX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100677
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026